| Date Initiated by Firm |
October 14, 2021 |
| Create Date |
November 02, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0190-2022 |
| Recall Event ID |
88840 |
| 510(K)Number |
K173739 K171708 K183456
|
| Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
| Product |
Arietta 850 Ultrasound-
Software Version: V1.0.0 through V4.1.3 |
| Code Information |
Serial Numbers:
205W3386 (01)04562122958974(11)171114(21)205W3386;
206F7900 (01)04562122958974(11)180926(21)206F7900;
206F7901 (01)04562122958974(11)180926(21)206F7901;
206F7936 (01)04562122958974(11)181113(21)206F7936;
206F7937 (01)04562122958974(11)181113(21)206F7937;
206F7940 (01)04562122958974(11)181113(21)206F7940;
206F7941 (01)04562122958974(11)181113(21)206F7941;
206F7942 (01)04562122958974(11)181113(21)206F7942;
206F7944 (01)04562122958974(11)181113(21)206F7944;
206F7945 (01)04562122958974(11)181113(21)206F7945;
206F7946 (01)04562122958974(11)181113(21)206F7946;
206F7947 (01)04562122958974(11)181114(21)206F7947;
G3002552 (01)04562122958974(11)20190115(21)G3002552;
G3024545 (01)04562122958974(11)190607(21)G3024545;
G3037885 (01)04562122958974(11)20190719(21)G3037885;
G3037887 (01)04562122958974(11)20190719(21)G3037887;
G3042405 (01)04562122958974(11)190829(21)G3042405;
G3042823 (01)04562122958974(11)20190807(21)G3042823;
G3042828 (01)04562122958974(11)20190808(21)G3042828;
G3045094 (01)04562122958974(11)20190822(21)G3045094;
G3052105 (01)04562122958974(11)20191008(21)G3052105
G3052118 (01)04562122958974(11)20191025(21)G3052118
G3055549 (01)04562122958974(11)20191118(21)G3055549
G3055550 (01)04562122958974(11)20191118(21)G3055550
G3055552 (01)04562122958974(11)20191118(21)G3055552
G3055553 (01)04562122958974(11)20191118(21)G3055553
G3055554 (01)04562122958974(11)20191118(21)G3055554
G3055555 (01)04562122958974(11)20191118(21)G3055555
G3060234 (01)04562122958974(11)20191206(21)G3060234
G3060254 (01)04562122958974(11)20191206(21)G3060254
G3060275 (01)04562122958974(11)20191216(21)G3060275
G3060278 (01)04562122958974(11)20191216(21)G3060278
G3060690 (01)04562122958974(11)200127(21)G3060690
G3071074 (01)04562122958974(11)20200227(21)G3071074
G3080785 (01)04562122958974(11)201105(21)G3080785
G3090450 (01)04562122958974(11)201225(21)G3090450
G3110884 (01)04562122958974(11)210401(21)G3110884
|
Recalling Firm/
Manufacturer |
FujiFilm Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg OH 44087-2371
|
| For Additional Information Contact |
Aaron Pierce
330-425-1313 Ext. 3720
|
Manufacturer Reason
for Recall |
Diagnostic ultrasound system with the specified
software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display
the measurement results correctly with two cardiology measurement functions:
Mitral Regurgitation Flow (MR Flow) Measurement;
Mitral Valve (MV) Measurement.
In addition there is an error in the instruction manual.
|
FDA Determined
Cause 2 |
Software design |
| Action |
Fujifi Film issued Medical Device Correction Notice letter dated 10/07/21 via courier on 10/14/21.
Letter states reason for recall, health risk and action to take:
Customers/Users are advised to accept the corrected software and manual as soon as available.
Advisory Notification applies to all customers and distributors of the ARIETTA 850 systems with software version V1.0.0 through V4.1.3, See following page for complete list of affected systems.
We will contact you to set up time to update the software and provide the revised manual. (7) Other Information:
For questions, comments, or concerns, please contact:
Aaron Pierce
Director, QA/RA
1959 Summit Commerce Park
Twinsburg, OH 44087
Phone (330) 425-1313 x2934, Fax (330) 963-0749
Email aaron.pierce@fujifilm.com |
| Quantity in Commerce |
38 units |
| Distribution |
Nationwide
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = Hitachi Healthcare Americas
510(K)s with Product Code = IYN and Original Applicant = Hitachi Healthcare Americas Corporation
|
